Shanghai's Brain-Computer Interface Breakthroughs: Steplink Med Enters NMPA Fast Track, Bodar Med Advances Ultrasound-Based BCI Toward Clinical Use

Source: Jiefang Daily

Reporter Yu Taoran

Yesterday, two brain-computer interface companies in Shanghai announced their research progress: the "Implantable Wireless Brain-Computer Interface System" developed by StairMed has entered the review process of the National Medical Products Administration (NMPA).Innovative HealthcareStairMed's device has entered the special review process, becoming the first invasive brain-computer interface product in China to enter the "green channel"; Xu Kailiang, founder of StairMed and researcher at Fudan University, introduced the progress of his team's development of "ultrasound brain-computer interface" at the finals of the 2025 "Innovate·In China" International Innovation and Entrepreneurship Competition. "Our technology is expected to achieve high spatiotemporal resolution full-brain functional analysis," Xu Kailiang told the judges.

Brain-computer interface is one of the future industries that China focuses on developing. In 2016, Musk founded Neuralink, making brain-computer interface a globally watched innovative track. However, the products of Neuralink have relatively high safety risks and may lead to consequences such as immune scarring and rejection reactions after surgery.

How to Reduce Safety Risks? StairMed Invented Ultra-Flexible Electrodes with a Diameter of Only 1/100 of a Hair Strand, and Their Softness Is Hundreds of Times That of Neuralink Products. After These Electrodes Produced in China Are Implanted in the Brain, Brain Tissue Can Hardly "Feel" the Invasion of the Electrode, Greatly Reducing the Risk of Tissue Damage and Immune Reactions.

Currently, StairMed and Huashan Hospital Affiliated with Fudan University are collaborating on a prospective clinical trial. "Based on the trial results, this brain-computer interface achievement has preliminarily realized motor control functions, helping patients regain partial self-care abilities," said Dr. Wu Jinsong, Chief Physician of the Neurosurgery Department at Huashan Hospital.

Li Xue, founder of StairMed and researcher at the Center for Excellence in Brain Science and Intelligence Technology of the Chinese Academy of Sciences, stated that after entering the "green channel" of the National Medical Products Administration, the company will accelerate the registration application and subsequent clinical research process, continuously promote the safety verification and large-scale application of its products, allowing brain-computer interface technology to be more widely applied in areas such as motor language function replacement, neurological disease treatment, and sensory perception restoration.

If StairMed has optimized Musk's brain-computer interface solution through independent innovation, then BodaMed is taking a different approach, with the potential to revolutionize Musk's solution using ultrafast ultrasound technology.

Xu Kailiang introduced that ultrafast ultrasound is an emerging ultrasound technology with a frame rate reaching tens of thousands of frames per second. Its spatiotemporal resolution is better than 10 milliseconds and 10 micrometers, which significantly enhances imaging sensitivity compared to traditional ultrasound. Applying this technology to the detection of brain and spinal cord functional blood flow can surpass the two gold-standard techniques, fMRI (functional magnetic resonance imaging) and PET (positron emission tomography), capturing transient neurovascular coupling changes.

Currently, StairMed has developed an ultrasound cerebral blood flow imaging system, which is used in scientific research and clinical fields. In the neurosurgery department of Huashan Hospital, this product has been utilized for intraoperative examinations, achieving excellent clinical results. Building on this, the company is now developing an "ultrasound brain-computer interface" product, with the aim of achieving whole-brain function analysis through high spatiotemporal resolution cerebral blood flow imaging. As a form of mechanical vibration, ultrasound is characterized by its open and compatible nature, and it is expected to integrate with other technologies in the future to establish a closed-loop brain-computer interface for analyzing and modulating brain activity.

Safety is also an advantage of the "ultrasound brain-computer interface." The ultrasound probe is placed outside the skull, and its resolution is not affected. StairMed plans to miniaturize the device and then carry out clinical trials in two steps: first, through minimally invasive surgery, place the ultrasound probe outside the dura mater of the brain; after technical iteration, place the probe outside the skull to achieve truly non-invasive brain-computer interface detection.

"We hope to attract more investment through the competition and push the 'ultrasound brain-computer interface' technology into clinical use as soon as possible," Xu Kailiang told the reporter.

From November 12 to 14, the finals of the 2025 "Innovate·In China" International Innovation and Entrepreneurship Competition were held in Caohejing. This year, 7,380 participating projects went through multiple rounds of selection, with 50 high-quality projects ultimately advancing to the finals, covering cutting-edge fields such as next-generation information technology, biomedicine, high-end equipment, and new materials. The competition aims to discover and nurture hard-tech startups, helping Shanghai become the preferred destination for global tech startups.